Assessment of the Efficacy of Vitamin D-fortified Bread in Healthy Adults

Comparison of the Efficacy of Vitamin D-fortified Bread Versus Vitamin D Supplement in Healthy Adults: a Randomized Controlled Clinical Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02516254

Enrollment

Registered

2015-08-05

Start date

2015-01-31

Completion date

2015-04-30

Last updated

2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

vitamin D, fortified bread, efficacy, Vitamin D Deficiency

Brief summary

The aim of this study is to evaluate the efficacy of daily intake of fortified bread with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to vitamin D supplement.

Detailed description

Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Subjects will be assigned randomly to one of the three intervention groups: 1.fortified bread+placebo,2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of bread and supplement or placebo every day for 2 months. At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are improvement in vitamin D status and secondary outcome is improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis D.

Interventions

DIETARY_SUPPLEMENTplacebo

plain bread+placebo

DIETARY_SUPPLEMENTfortified bread

50 g of fortified bread + placebo daily

DIETARY_SUPPLEMENTsupplement

vitamin D supplement+ plain bread

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* 20 to 50 years * healthy subjects * no receiving vitamin D or omega-3 supplement in past 3 months

Exclusion criteria

* receiving vitamin D or omega-3 supplement during the study

Design outcomes

Primary

Measure	Time frame
25-hydroxyvitamin D (nmol/L)	8 weeks

Secondary

Measure	Time frame
serum triglyceride (mg/dL)	8 weeks
serum total cholesterol (mg/dL)	8 weeks
serum glucose (mg/dL)	8 weeks
serum HDL (mg/dL)	8 weeks
serum PTH (pg/mL)	8 weeks
serum LDL	8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026